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Terminated

CARESCAPE VC150 Vital Signs Monitor; Intended to monitor a single patient's vital signs at the site of care.

FDA Recall Z-2604-2016 · Posted 2016-08-19

Recalling FirmINNOKAS MEDICAL OY
Recall StatusTerminated
Product CodeMWI
Date Initiated2016-07-27
Date Terminated2017-04-19
Product Quantity1715 units

Reason for Recall

A software error on released software versions 1.6.12, 1.6.12F and 1.6.16 may give wrong time data to measurements.

Firm Action

Innokas Medical has notified the one US distributor on 7/27/16 via letter of the deficiency and correction of the device.

Root Cause

Software design

Distribution Pattern

AR, AZ, FL, IN, LA, MA, MI, NC, NJ, NM, NY, OH, PA, TN, WI

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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